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MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 Original Issue Date (Created): 8/20/2002 Most Recent Review Date (Revised): 3/29/2016 Effective Date: POLICY RATIONALE DISCLAIMER POLICY HISTORY 1/1/2017 PRODUCT VARIATIONS DEFINITIONS CODING INFORMATION DESCRIPTION/BACKGROUND BENEFIT VARIATIONS REFERENCES I. POLICY Routine SPECT imaging may be considered medically necessary for the evaluation of the following: Abscess localization in any part of the body. Bone o Assessment of osteomyelitis, to distinguish bone from soft tissue infection o Detection of spondylosis o Detection of fractures; o To differentiate between infectious, neoplastic, avascular or a traumatic process Brain o Localized epilepsy when all of the following are present Surgery planned or being considered Results of high-resolution MRI are negative, indeterminate, or inconsistent with symptoms and signs; o Differentiation of necrotic tissue from tumor of the brain o Differentiation between lymphomas and infections such as toxoplasmosis particularly in the immunosuppressed Chronic back pain Heart (myocardium); o Assessment of the functional and prognostic importance of angina o Diagnostic evaluation of patients with chest pain and uninterpretable or equivocal ECG changes caused by drugs, bundle branchy block, or left ventricular hypertrophy. o Assessment of congenital anomalies of coronary arteries. o Risk assessment or re-evaluation of disease in patients who are asymptomatic or have stable symptoms, with known atherosclerotic heart disease on catheterization or SPECT perfusion imaging, who have not had a revascularization procedure within the past two years; Page 1 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 o Detection of coronary artery disease in patients, without chest pain syndrome, with new-onset of diagnosed heart failure or left ventricular systolic dysfunction. o Evaluation of ischemic versus non-ischemic cardiomyopathy when cardiac catheterization / coronary angiography are contraindicated or unlikely to be performed. o Evaluation of myocardial perfusion and/or function before and after coronary artery bypass surgery or other re-perfusion procedures o Quantification and surveillance of myocardial infarction and prognostication in patients after infarction. o Preoperative assessment for non-cardiac surgery, when used to determine risk for surgery and/or perioperative management in: Patients with minor or intermediate clinical risk predictors and poor cardiac functional capacity Patients with intermediate or high likelihood of coronary heart disease, or patients with poor functional capacity undergoing high risk non-cardiac surgery. (See definitions). o Evaluation of ventricular function in patients with non-ischemic myocardial disease. o Evaluation of patients in whom an accurate measure of ejection fraction is needed to make a determination of whether to implant a defibrillator or biventricular pacemaker. o Evaluation of a patient receiving chemotherapeutic drugs which are potentially cardiotoxic (e.g. doxorubicin). Kidneys – for the diagnosis and treatment of renal diseases, conditions or disorders, including, but not limited to, the following: o Acute, chronic or recurrent kidney infections (e.g., pyelonephritis); o Pediatric patients with urinary tract infection o Assessing the integrity of renal parenchyma in cases of renal wasting diseases; o Congenital anomalies of the kidneys; o Evaluations of kidney tumors and trauma; o Renal cortical damage or defects; o Renal infarction or renal masses; o Vesicoureteral reflux in children. Liver; o Diagnosing and assessing hemangiomas of the liver Lung o Diagnosing pulmonary embolism by means of SPECT ventilation/perfusion scintigraphy Lymphoma o To distinguish tumor from necrosis Neuroendocrine tumors (diagnosis and staging) Parathyroid tumors Spleen; Page 2 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 Other applications of SPECT scanning are considered investigational, including, but not limited to the evaluation of the following as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Attention Deficit and hyperactivity disorder Chronic fatigue syndrome Colorectal carcinoma Dementias, Head and neck tumors, Psychiatric disorders, Malignancies other than those listed above as medically necessary Motor neuron disorders, Neurological disorders, Neuropsychiatric disorders without evidence of cerebrovascular disease Psychiatric disorders, Pulmonary nodules, Staging of malignant lung cancer or mediastinal lymph node metastasis. Cerebrospinal fluid (CSF) flow SPECT imaging is also considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Cross-references: MP-2.304 Pervasive Developmental Disorders MP-5.022 Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging)/with Indium111 Capromab Pendetide (ProstaScint®) for Prostate Cancer MP-5.021 Scintomammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging II. PRODUCT VARIATIONS TOP This policy is applicable to all programs and products administered by Capital BlueCross unless otherwise indicated below. BlueJourney HMO* BlueJourney PPO* FEP PPO** * Refer to Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 220.12, Single Photon Emission Computed Tomography for additional indications. Also refer to Novitas Solutions Local Coverage Determination (LCD) L35083 Cardiovascular Nuclear Medicine Page 3 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 ** For SPECT scan of the heart refer to FEP Medical Policy Manual MP-6.01.20 Cardiac Applications of Positron Emission Scanning. The FEP Medical Policy manual can be found at: www.fepblue.org **The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDAapproved drugs, devices or biological products may be assessed on the basis of medical necessity III. DESCRIPTION/BACKGROUND TOP Single photon emission computed tomography (SPECT) describes a nuclear medicine imaging technique that shares some similarities to both computerized x-ray tomography (CT) scanning and positron emission tomography (PET) scanning. However, SPECT yields higher resolution three-dimensional images. To perform this procedure, a radiopharmaceutical diagnostic imaging agent is injected or inhaled into the targeted area from which it emits the radiation that produces the images. A specialized camera rotates around the body to acquire data from multiple angles. The data is then fed to a computer, which uses mathematical algorithms to reconstruct images of the body. While CT scans the anatomy of a body area, SPECT assesses the functioning. IV. RATIONALE TOP NA V. DEFINITIONS TOP CLINICAL RISK FACTORS – o History of ischemic heart disease o History of compensated or prior heart failure o History of cerebrovascular disease o Diabetes mellitus o Renal insufficiency HIGH RISK SURGERY – aortic and peripheral vascular surgery INTERMEDIATE RISK SURGERY – intraperitoneal and intrathoracic surgery, carotid endarterectomy, head and neck surgery, orthopedic surgery, prostate surgery. LOW RISK SURGERY – endoscopic procedures, superficial surgery, cataract surgery, breast surgery, ambulatory surgery POOR FUNCTIONAL CAPACITY = less than 4 mets Page 4 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 TOMOGRAPHY is a radiographic technique that allows a cross section of a specific area rather than a composite of all overlapping structures. VI. BENEFIT VARIATIONS TOP The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member’s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member’s benefit information or contact Capital for benefit information. VII. DISCLAIMER TOP Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member’s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VIII. CODING INFORMATION TOP Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Investigational and therefore not covered: CPT Codes® 78647 Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. Covered when medically necessary: CPT Codes® 78071 78072 78607 78710 78205 78803 78206 78807 78320 78451 78452 78469 78494 Page 5 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. Specific diagnosis coding does not apply to this policy. IX. REFERENCES TOP American College of Radiology ACR Appropriateness Criteria, Solitary Pulmonary Nodule Last reviewed 2012. [Website:] https://acsearch.acr.org/docs/69455/Narrative/. Accessed February 17, 2016. American College of Radiology: ACR Practice Guidelines for the Performance of Single Photon Emission Computed Tomography (SPECT) Brain Perfusion and Brain Death Studies Practice Guideline 2007 (Resolution 21). [Website] http://www.acr.org/ Accessed February 17, 2016. Bennett S. Greenspan S, et al. The Society of Nuclear Medicine Procedure Guideline for Parathyroid Scintigraphy Version 3.0 June 2004. [Website]: http://interactive.snm.org. Accessed February 17, 2016. Carr, ER, Contractor K, Remidos D, Burke, M. Can parathyroidectomy for primary hyperparathyroidism be carried out as a day-case procedure? J Laryngo 2006; 1-3. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 220.12, Single Photon Emission Computed Tomography (SPECT). 10/1/02. CMS [Website]: http://www.cms.hhs.gov. Accessed February 17, 2016. Chou K, Diagnosis of Parkinson Disease. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated February 10, 2016. [Website] www.uptodate.com Accessed February 17, 2016. Cooper A, Calvert N, Skinner J, Sawyer L, Sparrow, K, Timmis A, Turnbull, N, Cotterell M, Hill D, Adams P, Ashcroft J, Clark L, Coulden R, Hemingway H, James C, Jarman H, Kendall J, Lewis P, Patel K, Smeeth, L, Taylor J. (2010) Chest pain of recent onset: Assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. London: National Clinical Guideline Centre for Acute and Chronic Conditions [Website]: https://www.nice.org.uk/guidance/cg95 Accessed February 17, 2016. Domenico Rubello, Maria Rosa Pelizzo, et al. Radioguided surgery of primary hyperparathyroidism using the low-dose 99mTc-Sestamibi protocol: multiinstitutional experience from the Italian Study Group on Radioguided Surgery and Immunoscintigraphy (GISCRIS) J Nucl Med 2005; 46: 220-226. Doweiko J. AIDS-related Lymphomas: Primary Central Nervous System Lymphoma. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated November 19, 2013. Literature review current through: Jan 2016 [Website] : www.uptodate.com . Accessed February 17, 2016. Page 6 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 Gayed IW, Kim EE, Broussard WF, et al. The value of 99mmTc-sestamibi SPECT/CT over conventional SPECT in the evaluation of parathyroid adenomas or hyperplasia J Nucl Med 2005; 46(2): 248-52. Gerber T, Manning W. Noninvasive Coronary Angiography with Cardiac Computed Tomography and Cardiovascular Magnetic Resonance. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; May 17, 2015 [Website] : www.uptodate.com Accessed February 17, 2016 Novitas Solutions Local Coverage Determination (LCD) L35083: Cardiovascular Nuclear Medicine Effective 12/31/15. [Website]: https://www.cms.gov/medicare-coveragedatabase/details/lcddetails.aspx?LCDId=35083&ContrId=323&ver=27&ContrVer=1&name=323*1&UpdateP eriod=649&bc=AQAAEAAAAAAAAA%3d%3d& Accessed February 17, 2016 Hirsch L, Hiba A. Neuroimaging in the Evaluation of Seizures and Epilepsy. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated February 12, 2015. [Website]: www.uptodate.com . Accessed February 17, 2016. Linwah Y, Silverberg S, Fuleihan, G. Preoperative Localization for Parathyroid Surgery in Patients with Primary Hyperparathyroidism. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated July 6, 2015 . [Website]: www.uptodate.com . Accessed February 17, 2016. NCCN Guidelines. Version 2 :2016. Bone Cancer [Website]: http://www.nccn.org Accessed February 17, 2016 Papaioannou G, Heller G. Exercise Radionuclide Myocardial Perfusion Imaging in the Diagnosis and Prognosis of Coronary Heart Disease. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated April 17, 2013. . [Website] : www.uptodate.com Last Accessed February 5, 2015. Schur P, Khoshbin S. Diagnostic Approach to Neuropsychiatric Manifestations of Systemic Lupus Erythematosus. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated November 9, 2014. Literature review current through Jan 2016 [Website] : www.uptodate.com. Accessed February 17, 2016 Soman P, Udelson J. Assessment of Myocardial Viability by Nuclear Imaging in Coronary Heart Disease. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated January 13, 2016Website] : www.uptodate.com. Accessed February 17, 2016. Theriault, R, Brown, E, Demers L, et al. NCCN Task Force Report: Bone Health and Cancer Care. Journal of the National Comprehensive Cancer Network Volume 7 Supplement 3 |June 2009. [Website] http://www.nccn.org Accessed February 17, 2016. Taber's Cyclopedic Medical Dictionary, 19th edition. X. POLICY HISTORY MP 5.031 TOP CAC 2/25/03 CAC 4/29/03 Page 7 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 CAC 2/24/04 CAC 10/26/04 CAC 11/29/05 CAC 10/31/06 CAC 11/27/07 CAC 1/29/08 CAC 1/27/09 Consensus 7/1/09 Cross-Reference for Pervasive Developmental Disorders CAC 1/26/10 Consensus review CAC Effective date of variation: 3/22/11 Minor revision. Medicare variation changed for myocardial perfusion test to refer to new LCD L 31187 Cardiovascular Nuclear Medicine. CAC 2/28/12 Deleted first paragraph in policy describing types of SPECT scans not included in this policy. Policy reviewed by ALLMed. Bone – specific indications were added. o Assessment of osteomyelitis, to distinguish bone from soft tissue infection o Detection of spondylosis o Detection of fractures; o To differentiate between infectious, neoplastic, avascular or a traumatic process Chronic back pain – added as a new indication Liver – specific indication added -diagnosing and assessing hemangiomas of the liver Lung – specific indications added -diagnosing pulmonary embolism by means of ventilation/perfusion scintigraphy. Lymphoma – added as a new indication - to distinguish tumor from necrosis Heart (myocardium) –specific criteria adopted for all plans. Taken from Medicare policy. Inflammation or Infection- specific indication added - localization of abscess, for suspected or known localized infection or inflammatory process Brain – specific indications added. o Pre-operative localization of partial seizure activity in anticipation of seizurerelated surgery. o Differentiation between lymphomas and infections such as toxoplasmosis particularly in the immunosuppressed o Differentiation of necrotic tissue from tumor of the brain. Neuroendocrine tumors – added as a new indication Parathyroid tumors– deleted “for preop scanning” CAC 6/4/13, Consensus list review. Administrative code review complete CAC 3/25/14 Consensus. No change to policy statements. References updated. CAC 3/24/15 Consensus review. No changes to the policy statements. References updated. Medicare variation updated. Coding reviewed. 11/2/15 Administrative change. LCD number changed from L31187 to L35085 due to Novitas update to ICD-10. Page 8 MEDICAL POLICY POLICY TITLE SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) POLICY NUMBER MP-5.031 12/31/15 Administrative change. LCD number changed from L35085 to L35083 by Novitas – criteria revised. 1/21/16- Admin correction to this update. CAC 3/29/16 Consensus review. No change to policy statements. References updated. Added FEP variation for SPECT scan of the heart - refer to FEP Medical Policy Manual MP-6.01.20 Cardiac Applications of Positron Emission Scanning. Standard FEP variation applies to other indications. Coding reviewed. Admin Update 1/1/17 Variation reformatting. Top Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 9